Intramedullary implants for replacing lost bone

ABSTRACT

A bone transport system includes a nail having a proximal end and a distal end, the proximal end configured for securing to a first portion of bone, the distal end configured for securing to a second portion of bone. The system includes a housing having a wall with a longitudinal opening extending a length along a portion thereof. The system further includes a transport sled having a length that is shorter than the length of the longitudinal opening, the transport sled configured for securing to a third portion of bone, the transport sled further configured to be moveable along the longitudinal opening. The system further includes a magnetic assembly disposed within the nail and configured to be non-invasively actuated by a moving magnetic field, wherein actuation of the magnetic assembly moves the transport sled along the longitudinal opening. The system further includes a ribbon extending on opposing sides of the transport sled and substantially covering the longitudinal opening.

INCORPORATION BY REFERENCE TO ANY PRIORITY APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.14/451,190 (Dkt. No. ELPSE.025C1), filed Aug. 4, 2014, which is acontinuation of U.S. patent application Ser. No. 13/655,246 (Dkt. No.ELPSE.025A), filed Oct. 18, 2012, now U.S. Pat. No. 9,044,281. Any andall applications for which a foreign or domestic priority claim isidentified in the Application Data Sheet as filed with the presentapplication are hereby incorporated by reference under 37 CFR 1.57.

BACKGROUND OF THE INVENTION Field of the Invention

The field of the invention generally relates to medical devices fortreating disorders of the skeletal system.

Description of the Related Art

Distraction osteogenesis is a technique which has been used to grow newbone in patients with a variety of defects. For example, limblengthening is a technique in which the length of a bone (for example afemur or tibia) may be increased. By creating a corticotomy, orosteotomy, in the bone, which is a cut through the bone, the tworesulting sections of bone may be moved apart at a particular rate, suchas one (1.0) mm per day, allowing new bone to regenerate between the twosections as they move apart. This technique of limb lengthening is usedin cases where one limb is longer than the other, such as in a patientwhose prior bone break did not heal correctly, or in a patient whosegrowth plate was diseased or damaged prior to maturity. In somepatients, stature lengthening is desired, and is achieved by lengtheningboth femurs and/or both tibia to increase the patient's height.

Bone transport is a similar procedure, in that it makes use ofosteogenesis, but instead of increasing the distance between the ends ofa bone, bone transport fills in missing bone in between. There areseveral reasons why significant amounts of bone may be missing. Forexample, a prior non-union of bone, such as that from a fracture, mayhave become infected, and the infected section may need to be removed.Segmental defects may be present, the defects often occurring fromsevere trauma when large portions of bone are severely damaged. Othertypes of bone infections or osteosarcoma may be other reasons for alarge piece of bone that must be removed or is missing.

Limb lengthening is often performed using external fixation, wherein anexternal distraction frame is attached to the two sections of bone bypins which pass through the skin. The pins can be sites for infectionand are often painful for the patient, as the pin placement site remainsa somewhat open wound “pin tract” throughout the treatment process. Theexternal fixation frames are also bulky, making it difficult for patientto comfortably sit, sleep and move. Intramedullary lengthening devicesalso exist, such as those described in U.S. Patent ApplicationPublication No. 2011/0060336, which is incorporated by reference herein.Bone transport is typically performed by either external fixation, or bybone grafting.

In external fixation bone transport, a bone segment is cut from one ofthe two remaining sections of bone and is moved by the externalfixation, usually at a rate close to one (1.0) mm per day, until theresulting regenerate bone fills the defect. The wounds created from thepin tracts are an even worse problem than in external fixation limblengthening, as the pins begin to open the wounds larger as the pins aremoved with respect to the skin. In bone grafting, autograft (from thepatient) or allograft (from another person) is typically used to createa lattice for new bone growth. Bone grafting can be a more complicatedand expensive surgery than the placement of external fixation pins.

SUMMARY OF THE INVENTION

In one embodiment of the invention, a bone transport system includes anail having a proximal end and a distal end, the proximal end configuredfor securing to a first portion of bone, the distal end configured forsecuring to a second portion of bone. The system includes a housinghaving a wall with a longitudinal opening extending a length along aportion thereof. The system further includes a transport sled having alength that is shorter than the length of the longitudinal opening, thetransport sled configured for securing to a third portion of bone, thetransport sled further configured to be moveable along the longitudinalopening. The system further includes a magnetic assembly disposed withinthe nail and configured to be non-invasively actuated by a movingmagnetic field, wherein actuation of the magnetic assembly moves thetransport sled along the longitudinal opening. The system furtherincludes a ribbon extending on opposing sides of the transport sled andsubstantially covering the longitudinal opening.

In another embodiment of the invention, a bone transport system includesa nail having a proximal end and a distal end, the proximal endconfigured for securing to a first portion of bone, the distal endconfigured for securing to a second portion of bone. The system furtherincludes a housing section having a wall with a longitudinal openingextending along a portion thereof and having a length. The systemfurther includes a transport sled having a length that is shorter thanthe length of the longitudinal opening, the transport sled configuredfor securing to a third portion of bone, the transport sled furtherconfigured to move along the longitudinal opening. The system furtherincludes a magnetic assembly disposed within the nail and configured tobe non-invasively actuated by a moving magnetic field, wherein actuationof the magnetic assembly moves the transport sled along the longitudinalopening. The system further includes a dynamic cover which is configuredto cover substantially all of the portion of the longitudinal openingthat is not occupied by the transport sled independent of the positionof the transport sled along the length of the longitudinal opening.

In another embodiment of the invention, a method for performing a bonetransport procedure includes placing a bone transport system within anintramedullary canal of a bone, the bone transport system comprising anail having a proximal end and a distal end, a housing section having awall with a longitudinal opening extending along a portion thereof, atransport sled disposed in the longitudinal opening and configured tomove along the longitudinal opening in response to actuation of amagnetic assembly disposed within the nail, and a dynamic coverconfigured to cover substantially all of the longitudinal opening notoccupied by the transport sled. The method further includes securing theproximal end of the nail to a first portion of bone, securing the distalend of the nail to a second portion of bone, and securing a thirdportion of bone to the transport sled. The method further includesapplying a moving magnetic field to the magnetic assembly to actuate themagnetic assembly and cause the transport sled to move along thelongitudinal opening, wherein the dynamic cover substantially covers allof the longitudinal opening regardless of the location of the transportsled within the longitudinal opening.

In another embodiment of the invention, a bone transport system includesa nail having a proximal end and a distal end, the proximal endconfigured for securing to a first portion of bone, the distal endconfigured for securing to a second portion of bone. The system furtherincludes a housing section having a wall with a longitudinal openingextending along a portion thereof and having a length. The systemfurther includes a transport sled having a length that is shorter thanthe length of the longitudinal opening, the transport sled configuredfor securing to a third portion of bone, the transport sled disposedwithin the longitudinal opening and further configured to move along thelongitudinal opening. The system further includes a magnetic assemblydisposed within the nail and configured to be non-invasively actuated bya moving magnetic field, wherein actuation of the magnetic assemblyturns a lead screw, which in turn moves the transport sled along thelongitudinal opening, and wherein the lead screw includes a threadedsurface having a coating thereon, the coating selected from eithermolybdenum disulfide or amorphous diamond-like carbon.

In another embodiment of the invention, and implantable dynamicapparatus includes a nail having a first portion and a second portion,the first portion of the nail configured for securing to a first portionof bone, the second portion of the nail configured for securing to asecond portion of bone, the second portion of the nail configured to belongitudinally moveable with respect to the first portion of the nail,wherein the second portion of the nail includes an internally threadedfeature. The apparatus further includes a magnetic assembly configuredto be non-invasively actuated by a moving magnetic field. The apparatusfurther includes a lead screw having an externally threaded portion, thelead screw coupled to the magnetic assembly, wherein the externallythreaded portion of the lead screw engages the internally threadedfeature of the second portion of the nail, wherein actuation of themagnetic assembly turns the lead screw, which in turn changes thelongitudinal displacement between the first portion of the nail and thesecond portion of the nail. The apparatus further includes a firstabutment surface coupled to the lead screw, a second abutment surfacecoupled to the second portion of the nail, and wherein the turning ofthe lead screw in a first direction causes the first abutment to contactthe second abutment, stopping the motion of the lead screw with respectto the second portion of the nail, and wherein subsequent turning of thenail in a second direction is not impeded by any jamming between theinternally threaded feature and the externally threaded portion.

In another embodiment of the invention, a bone transport system includesa nail having a proximal end and a distal end, the proximal endconfigured for securing to a first portion of bone, the distal endconfigured for securing to a second portion of bone. The system furtherincludes a housing section having a wall with a longitudinal openingextending along a portion thereof. The system further includes atransport sled configured for securing to a third portion of bone, thetransport sled disposed within the longitudinal opening and furtherconfigured to be moveable along the longitudinal opening, the transportsled having a first stopping surface. The system further includes amagnetic assembly disposed within the nail and configured to benon-invasively actuated by a moving magnetic field, wherein actuation ofthe magnetic assembly rotates a lead screw operatively coupled theretoand moves the transport sled along the longitudinal opening. The systemfurther includes a stop secured to the lead screw and having a secondcontact surface, and wherein when the first contact surface contacts thesecond contact surface in response to rotation of the lead screw, thestop is configured to radially expand and prevent additional rotation ofthe lead screw.

In another embodiment of the invention, a non-invasively adjustableimplant includes a nail having a first portion and a second portion, thefirst portion of the nail configured for securing to a first portion ofbone, the second portion of the nail configured for securing to a secondportion of bone, the second portion of the nail configured to belongitudinally moveable with respect to the first portion of the nail.The implant further includes a magnetic assembly configured to benon-invasively actuated. The system further includes a cylindricalpermanent magnet having at least two radially-directed poles, thecylindrical permanent magnet configured to be turned by a movingmagnetic field, the cylindrical permanent magnet held by a magnetholder, the magnet holder rotationally coupled to the magnetic assembly,wherein actuation of the magnetic assembly changes the longitudinaldisplacement between the first portion of the nail and the secondportion of the nail. The implant further includes a friction applicatorwhich couples the magnet holder to the cylindrical permanent magnet,wherein the friction applicator is configured to apply a staticfrictional torque to the magnet so that when a moving magnetic fieldcouples to the cylindrical permanent magnet at a torque below the staticfrictional torque, the cylindrical permanent magnet and the magnet holdturn in unison, and when a moving magnetic field couples to thecylindrical permanent magnet at a torque above the static frictionaltorque, the cylindrical permanent magnet turns while the magnet holderremains rotationally stationary.

In another embodiment of the invention, a bone transport system includesa nail having a proximal end and a distal end, the proximal endconfigured for securing to a first portion of bone, the distal endconfigured for securing to a second portion of bone. The system furtherincludes a housing section having a wall with a longitudinal openingextending along a portion thereof. The system further includes atransport sled configured for securing to a third portion of bone, thetransport sled disposed within the longitudinal opening and furtherconfigured to be moveable along the longitudinal opening. The systemfurther includes a magnetic assembly disposed within the nail andconfigured to be non-invasively actuated by a moving magnetic field,wherein actuation of the magnetic assembly moves the transport sledalong the longitudinal opening, the magnetic assembly having a magnetichousing containing a permanent magnet therein and a biasing memberinterposed between the magnetic housing and the permanent magnet,wherein the magnetic housing and the permanent magnet are rotationallylocked by the biasing member up to a threshold torque value.

In another embodiment of the invention, a bone transport system includesa nail having a proximal end and a distal end, the proximal endconfigured for securing to a first portion of bone, the distal endconfigured for securing to a second portion of bone. The system furtherincludes a housing having a wall with a longitudinal opening extendingalong a portion thereof. The system further includes a transport sleddisposed within the longitudinal opening and further configured to bemoveable along the longitudinal opening. The system further includes amagnetic assembly disposed within the nail and configured to benon-invasively actuated by a moving magnetic field, wherein actuation ofthe magnetic assembly rotates a lead screw operatively coupled to a nutmoveable along a length of the lead screw in response to rotationthereof. The system further includes a ribbon secured to the nut at oneend and secured to the transport sled at an opposing end, the ribbonpassing over at least one pulley, wherein movement of the nut in a firstdirection translates into movement of the transport sled in a second,opposing direction.

In another embodiment of the invention, a method for performing a bonetransport procedure includes preparing the medullary canal of a bone forplacement of a nail configured to change its configuration at leastpartially from a moving magnetic field supplied by an externaladjustment device, the change in configuration including thelongitudinal movement of a transport sled. The method further includesplacing a nail within the medullary canal of the bone, securing a firstend of the nail to a first portion of the bone, and securing a secondend of the nail to a second portion of the bone. The method furtherincludes storing information in the external adjustment device, theinformation including the orientation of the nail within the bone andthe direction of planned movement of the transport sled.

In another embodiment of the invention, a bone transport system includesa nail having a first end and a second end, the first end configured forsecuring to a first portion of bone, the second end configured forsecuring to a second portion of bone. The system further includes amagnetic assembly disposed within the nail and configured to benon-invasively actuated by a moving magnetic field, wherein actuation ofthe magnetic assembly rotates a lead screw operatively coupled to a nutmoveable along a length of the lead screw in response to rotationthereof, the nut containing at least one pulley affixed thereto. Thesystem further includes at least one pulley disposed within the nail atthe first end. The system further includes at least one tension linefixed relative to the first end and passing over both the at least onepulley of the nut and the at least one pulley disposed within the nailat the first end, and wherein the tension line is configured to besecured to a third portion of bone.

In another embodiment of the invention, a bone transport system includesa nail having a proximal end and a distal end, the proximal endconfigured for securing to a first portion of bone, the distal endconfigured for securing to a second portion of bone. The system furtherincludes a housing section having a wall with a longitudinal openingextending along a portion thereof. The system further includes atransport sled configured for securing to a third portion of bone, thetransport sled disposed within the longitudinal opening and furtherconfigured to be moveable along the longitudinal opening. The systemfurther includes a magnetic assembly disposed within the nail andconfigured to be non-invasively actuated by a moving magnetic field,wherein actuation of the magnetic assembly moves the transport sledalong the longitudinal opening, and wherein the nail has an ultimatefailure torque greater than 19 Newton-meters.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 illustrates an intramedullary bone transport device for replacinglost bone according to one embodiment.

FIG. 2 illustrates a longitudinal section of the intramedullary bonetransport device of FIG. 1.

FIG. 3 illustrates detail 3 of FIG. 2.

FIG. 4 illustrates detail 4 of FIG. 2.

FIG. 5 illustrates the intramedullary bone transport device securedwithin the medullary canal of a tibia, prior to transporting a bonesegment.

FIG. 6 illustrates the intramedullary bone transport device securedwithin the medullary canal of a tibia, after transporting a bonesegment.

FIG. 7 illustrates an exploded view of the internal components locatedwithin an enclosed housing portion of an actuator of the intramedullarybone transport device.

FIG. 8 illustrates an enclosed housing portion of the actuator of theintramedullary bone transport device.

FIG. 9 illustrates a screw assembly for securing a transport sled to abone segment.

FIG. 10 illustrates detail view of an end stop for avoiding jamming of atransport sled.

FIG. 11 illustrates a spring friction slip clutch incorporated into amagnetic assembly.

FIG. 12 illustrates a longitudinal section of FIG. 11, taken along lines12-12.

FIG. 13 illustrated a cross-section of FIG. 11, taken along lines 13-13.

FIG. 14 illustrates an adjustable friction slip clutch incorporated intoa magnetic assembly.

FIG. 15 illustrates detail 15 of FIG. 14.

FIG. 16 illustrates a wave disc used as a spring component in the slipclutch of FIGS. 14 and 15.

FIG. 17 illustrates the actuator of an intramedullary bone transportdevice having a dynamic cover according to a first embodiment.

FIG. 18 illustrates the actuator of an intramedullary bone transportdevice having a dynamic cover according to a second embodiment.

FIG. 19 illustrates the actuator of an intramedullary bone transportdevice having a dynamic cover according to a third embodiment.

FIG. 20 is a longitudinal section of the actuator of FIG. 18.

FIG. 21 illustrates detail 21 of the actuator of FIG. 20.

FIG. 22 illustrates internal components of an external adjustment devicefor non-invasively adjusting an intramedullary bone transport deviceaccording to one embodiment.

FIG. 23 illustrates an external adjustment device in a configuration foradjusting an intramedullary bone transport device implanted within thefemur.

FIG. 24 illustrates an external adjustment device in a configuration foradjusting an intramedullary bone transport device implanted within thetibia.

FIG. 25A illustrates the transport sled of the intramedullary bonetransport device of FIG. 17.

FIG. 25B illustrates a cross-section of the transport sled in the openhousing of the intramedullary bone transport device of FIG. 17.

FIG. 26 illustrates the transport sled of the intramedullary bonetransport device of FIG. 18.

FIG. 27 illustrates an alternative embodiment of an end stop prior toreaching the end of travel.

FIG. 28 illustrates the end stop of FIG. 27 at the end of travel in onedirection.

FIG. 29 illustrates an additional embodiment of an end stop prior toreaching the end of travel.

FIG. 30 illustrates the end stop of FIG. 29 at the end of travel in onedirection.

FIG. 31A illustrates an intramedullary bone transport device having areverse block and tackle arrangement.

FIG. 31B illustrates the intramedullary bone transport device of FIG.31A with a portion of the housing removed.

FIG. 32 illustrates detail 32 of FIG. 31B with portions removed forclarity.

FIG. 33 illustrates an intramedullary bone transport device having analternative drive system.

FIG. 34 illustrates a longitudinal section of the intramedullary bonetransport device of FIG. 33 taken along lines 34-34.

FIG. 35 illustrates detail 35 of FIG. 34.

FIG. 36 illustrates detail 36 of FIG. 34.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT

FIG. 1 illustrates an intramedullary bone transport device 100 in a“nail” configuration, having an actuator 102, a first extension rod 104coupled to the actuator 102 at a first end 108 of the intramedullarybone transport device 100, and a second extension rod 106 coupled to theactuator 102 a second end 110 of the intramedullary bone transportdevice 100. First extension rod 104 and second extension rod 106 aresecured to actuator 102 by set screws 112, 114. A variety of differentextension rods are available, each having a particular angulation andlength. In FIG. 1, first extension rod 104 is angled for use in theproximal tibia while second extension rod 106 is straight for use in thedistal tibia. Multiple configurations are contemplated for tibial use,as well as antegrade use in the femur and retrograde use in the femur.Holes 116, 118, 120, 122, 124 are configured with specific diameters andorientations, in order to accommodate bone screws 126, 128, 130, 132,134 for securing intramedullary bone transport device 100 to the bone asseen in FIGS. 5 and 6. FIGS. 5 and 6 show the intramedullary bonetransport device 100 secured in the medullary canal of a tibia 136. Thetibia 136 is shown having a proximal portion 138 and a distal portion140. Additionally, there is a missing section 142 of tibia 136. The bonethat was originally in this missing section 142 may be missing becauseof several reasons. It may have been destroyed because of severe traumato this area of the tibia. It may also have been removed as part of atreatment of osteosarcoma in this area. The intramedullary bonetransport device 100 facilitates the replacement of this bone byfacilitating the controlled movement of a bone segment 144, which can becut from one of the two portions 138, 140 of the tibia 136. In the caseillustrated in FIGS. 5 and 6, the bone segment 144 is cut from theproximal portion 138 of the tibia 136.

Returning to FIG. 1, the actuator 102 includes an enclosed housing 146and an open housing 148. The open housing 148 contains a longitudinalslit 150 on one side along which a transport sled 152 is configured foraxial movement. Longitudinal slit has a length of 140 mm, but can be arange of lengths, depending on the desired amount of bone transport.Referring more specifically to FIGS. 2, 3 and 4, the transport sled 152includes a moveable transport tube 154 having an internal nut 156. Asupport stage 158 is attached to the transport tube 154, the supportstage 158 being configured for axial movement within the longitudinalslit 150 of the open housing 148. The internal nut 156 is threaded andcoupled to a correspondingly threaded lead screw 160, so that rotationof the lead screw 160 in a first rotational direction causes thetransport tube 154 and support stage 158 (i.e., transport sled 152) tomove along the longitudinal slit 150 in a first axial direction androtation of the lead screw 160 in a second, opposite rotationaldirection causes the transport sled 152 to move along the longitudinalslit 150 in a second axial direction, opposite of the first axialdirection. Internal nut 156 may have female threads cut directly intothe transport tube 154. Alternatively, internal nut 156 may haveexternal male threads and the transport tube 154 may have internalfemale threads, so that the internal female threads of the transporttube 154 and the external male threads of the internal nut 156 create ahelical engagement surface. The two parts may be held together at thissurface with adhesive, epoxy, etc. A representative thread design is 80turns per inch.

Intramedullary bone transport device 100 is configured to allowcontrolled, precise translation of the transport sled 152 along thelength of the longitudinal slit 150 by non-invasive remote control, andthus controlled, precise translation of the bone segment 144 that issecured to the transport sled 152. Within the enclosed housing 146 ofthe actuator 102 is located a rotatable magnetic assembly 176. Furtherdetail can be seen in FIGS. 7 and 8. The magnetic assembly 176 includesa cylindrical, radially-poled permanent magnet 162 (FIG. 22) containedwithin a magnet housing 164 having an end cap 166. The permanent magnet162 may include rare earth magnet materials, such asNeodymium-Iron-Boron. The permanent magnet 162 has a protective Phenoliccoating and may be held statically within the magnet housing 164 and endcap 166 by epoxy or other adhesive. The magnet housing 164, end cap 166and epoxy form a seal to further protect the permanent magnet 162.Magnet housing 164 may also be welded to end cap 166 to create ahermetic seal. End cap 166 includes cylindrical extension or axle 168which fits within the inner diameter of a radial bearing 170, allowingfor low friction rotation. Outer diameter of radial bearing 170 fitswithin cavity 172 of an actuator end cap 174 as seen, for example, inFIG. 4. Actuator end cap 174 may be welded to enclosed housing 146 ofactuator 102. Referring to FIG. 7, the magnetic assembly 176 terminatesat an opposing end in a first sun gear 178 which is integral to magnethousing 164. First sun gear 178 may also be made as a separate componentand secured to magnet housing 164, for example by welding. First sungear 178 turns with rotation of magnetic assembly 176 (in a 1:1 fashion)upon application of a moving magnetic field applied to the patient froman external location. The first sun gear 178 is configured to insertwithin opening 190 of a first gear stage 180 having three planetarygears 186 which are rotatably held in a frame 188 by axles 192. Secondsun gear 194, which is the output of the first gear stage 180, turnswith frame. The identical components exist in second gear stage 182,which outputs to a third sun gear 196, and third gear stage 184, whichoutputs to an output shaft 198 as best seen in FIG. 4. Along the lengththat the gear stages 180, 182, 184 extend, the inner wall 200 ofenclosed housing 146 (as seen in FIG. 8) has internal teeth 202 alongwhich the externally extending teeth 204 of the planetary gears 186engage, as they turn. Each gear stage illustrated has a 4:1 gear ratio,so the output shaft 198 turns once for every 64 turns of the magneticassembly 176. The output shaft 198 is coupled to lead screw 160 by a pin206 (FIG. 4) which passes through holes 208 in a lead screw coupling cup240 (FIG. 7) which is welded to output shaft 198 and a hole 210 in thelead screw 160 (FIG. 4). Pin 206 is held in place by retaining cylinder242. A pin 206 diameter of 0.055 inches on a pin 206 made from 400series stainless steel allows for a tensile break force of over 600pounds between the lead screw 160 and the lead screw coupling cup 240.The torque applied on the magnetic assembly 176 by the action of therotating magnetic field on the cylindrical permanent magnet 162, istherefore augmented on the order of 64 times in terms of the turningtorque of the lead screw 160. This allows the transport sled 152 to beable to move with high precision. Returning to FIGS. 5 and 6, bonesegment 144 is attached to transport sled 152 by three screw assemblies212, which engage with internally threaded holes 214 of the supportstage 158 of the transport sled 152. Because of the 64:1 gear ratio, theintramedullary bone transport device is able to axially displace thebone segment 144 against severe resisting forces, for example thosecreated by soft tissue. A thrust bearing 262 (FIG. 4) is sandwichedbetween the lead screw 160 and the gear stages 180, 182, 184 in order toprotect the gear stages 180, 182, 184 and the magnetic assembly 176 fromhigh compressive forces. The thrust bearing 262 butts up against aflange 264 inside the enclosed housing 146. A shim spacer 270 can beadded to assembly in order to maintain a desired amount of axial play.Shim spacer 270 can be a tube, chosen from a variety of lengths tooptimize this axial spacing of the components.

FIG. 9 illustrates a bone segment 144 and a screw assembly 212 forsecuring the bone segment 144 to the support stage 158 of the transportsled 152. For clarity purposes, the remainder of the tibia is not shown,nor is the transport sled, which would be located inside the reamedmedullary canal of the bone segment 144. A drill site 220 is chosen fordrilling through the bone segment 144. This drill site 220 correspondsto one of the threaded holes 214 of the support stage 158 of thetransport sled 152, and is located using fluoroscopy or surgicalnavigation during the surgical procedure. The holes 214 themselves maybe made with radiopaque markings to further locate them. The cortex of asingle wall of the bone segment 144 is drilled at the drill location 220to make a pilot hole. A conventional tap (not shown) may then be used tocut internal threads in the bone at the drill location. Cannulated screw216 is then secured into the tapped hole with external threads 222engaging with tapped threads. Alternatively, if the cannulated screw 216is self-tapping, then the initial hole need only be piloted. Cannulatedscrew is tightened into place with a hex driver, which engages withfemale hex 226. Torx® shapes may be used instead of hex shapes. Innerscrew 218, having a head 228 and a threaded shaft 230 is then placedthrough a non-threaded through hole 224 in the cannulated screw 216 andthreaded shaft 230 is engaged with and tightened into threaded hole 214of the support stage 158 of the transport sled 152. Hex driver is placedinto female hex 232 to tighten inner screw 218. As illustrated in FIGS.5 and 6, there may be three of these connections made, to connect threescrew assemblies 212 with the three threaded screw holes 214 of thesupport stage 158 of the transport sled 152, though at times it might bedesired to make fewer than three connections or even more than threeconnections.

Referring back to FIG. 4, the gear stages 180, 182, 184 and the magneticassembly 176 are protected from any biological material that may enterlongitudinal slit 150, by a dynamic seal assembly 234. The lead screw160 includes a long threaded portion 236 and a smooth diameter(non-threaded) portion 238. An O-ring 244 having an “X” cross-sectionseals over the outer diameter of the smooth diameter portion 238 andmaintains the seal during rotation. A retaining structure 246 is weldedwith termination 248 of enclosed housing 146 and termination 250 of openhousing at weld point 252. A face 254 of retaining structure 246 servesas an axial abutment of O-ring 244 while longitudinal extension 256 ofretaining structure 246 retains O-ring 244 at its outer diameter. Theretaining structure 246 also further retains thrust bearing 262. A sealgland 258 presses or snaps in place within the inner diameter ofenclosed portion 260 of open housing, to further retain O-ring 244. TheO-ring 244 material may be EPDM or other similarly performing material.

The majority of components in the intramedullary bone transport devicecan be made of titanium, or titanium alloys, or other metals such asstainless steel or cobalt chromium. Bearings 170, 262 and pin 206 can bemade of 400 series stainless steel. A 10.7 mm diameter actuator having alongitudinal slit 150 length of approximately 134 mm has a totaltransport length of 110 mm. A 10.7 mm diameter actuator having alongitudinal slit 150 length of approximately 89 mm allows for a totaltransport length of 65 mm. A torsional finite element analysis wasperformed on a Titanium-6-4 alloy actuator having these dimensions. Theyield torque was 25 Newton-meters. This compares favorably to commonlyused trauma nails, some of which experience failure (ultimate torque) at19 Newton-meters. Yield torque is defined as the torque at which thenail begins to deform plastically, and thus the ultimate torque of the10.7 mm diameter actuator is above the 25 Newton-meter yield torque.

In FIGS. 2 through 4, the transport sled 152 abuts end stops 266, 268 ateach respective end of its travel over the lead screw 160. FIG. 10illustrates an end stop 266 having a threaded inner diameter 265configured for engaging the external threads 161 of lead screw 160. Pin276 is fit through hole 278 on end 272 of lead screw 160, and is sizedso that pin 276 fits within the inner diameter of counterbore 280 on endstop 266, thus limiting the axial travel of the end stop 266 in firstaxial direction 274. An analogous assembly may be used, using instead ac-clip which clips over a circumferential groove around the end 272 ofthe lead screw 160, thus replacing the hole 278 and the pin 276. Stillreferring to FIG. 10, a spring portion 282 is laser cut at one end ofend stop 266. End of transport tube 154 includes ledges 284, 286 whichare configured so that when transport tube 154 approaches end stop 266,the end 288 of spring portion 282 abuts one of the ledges 284, 286.Because the end stop 266 is held statically by combination ofcounterbore 280, threads 161, 265, and pin 276, the end 288 places atangential force on ledge 284 or 286 of transport tube 154. This causesspring portion 282 to increase in diameter until it is restrained byinner wall 290 of transport tube 154. The transport sled 152 is thusstopped axially, and even if a large torque is placed on permanentmagnet 162 by an external rotating magnetic field. Thus, even a largeforce that pushes transport sled 152 will not cause the transport tube154 to jam with lead screw 160, because the binding is between springportion 282 of end stop 266 and inner wall 290 of transport tube 154,and not between internal nut 156 and lead screw 160. When subsequently atorque is placed in an opposite direction on permanent magnet 162 by arotating magnetic field to move the transport sled 152 in a directionopposite the first axial direction 274 the tangential force between theend 288 and one of ledge 286 or 286 decreases, the spring portion 282decreases in diameter and the transport tube 154 is free to move awayfrom the end 288 of spring portion 282. End stop 268, seen at other endof lead screw 260 in FIG. 4, does not need a pin 276 or c-clip to holdit axially, but instead abuts the increase in diameter between thesmaller diameter threaded portion 236 of the lead screw 260 and thesmooth diameter portion 238 of the lead screw 260. The spring portion282 of end stop 266, 268 may alternatively be made from a split lockwasher, for simplicity and cost purposes.

FIGS. 11-13 illustrate an alternative magnetic assembly 376 having aspring friction slip clutch 377. The slip clutch 377 serves to limit themaximum amount of force applied on the body tissue, in this case thebone segment 144 and its neighboring soft tissue. It should be notedthat the assembly described may be used on other devices that are notbone transport devices, for example, limb lengthening devices, spinedistraction devices, jaw distraction devices and cranial distractiondevices in which too large of a torque applied to the permanent magnet162 results in too large of a distraction force, and thus possibledamage to tissue or pain. In the alternative magnetic assembly 376, thepermanent magnet 162 is held inside a magnetic housing 364 and an endcap 366 having a cylindrical extension or axle 368. In this case,however, the permanent magnet 162 is not bonded in place, but is held inplace with respect to the magnetic housing 364 and end cap 366 by theuse of friction. The magnetic housing 364 and end cap 366 are weldedtogether along a circumferential weld 292. A spring 294 is laser cut oretched from a material such as superelastic Nitinol®, and may be heatformed so that center portion 296 is axially displaced from outerportion 298, giving it spring capabilities in the axial direction. FIG.12 shows the spring 294 trapped between the permanent magnet 162 and theend cap 366, so that the center portion 296 of spring 294 is axiallycompressed and therefore places a normal force on the end 300 of thepermanent magnet 162. By controlling the material, the thickness and thedimensions of the spring 294, a controlled spring constant is achieved,thus applying a consistent normal force, and proportional frictionaltorque that must be overcome in order to allow permanent magnet 162 torotate freely within magnet housing 364 and end cap 366. For example, ina scoliosis distraction device, it is desired that at a torque up to twoinch-pounds (0.23 Newton-meter), the permanent magnet 162 and the magnethousing/end cap 364/366 remain static to each other, thus allowing themagnetic assembly 376 to turn the lead screw 160. In this application,the gear stages 180, 182, 184 may be omitted. This represents adistraction force of approximately 125 pounds (556 Newton), at whichdamage may occur to vertebrae at their attachment point to the implant.Above two inch-pounds, it may be desired that the spring 294 allow thepermanent magnet 162 to turn freely with respect to the magnethousing/end cap 364/366, thus stopping the turning of the lead screw.Alternatively, in a bone transport or limb lengthening device havinggear stages 180, 182, 184, and a total gear ratio of 64:1, it may bedesired that this slippage occur at 0.046 inch-pounds (0.005Newton-meter). This limit would potentially be desired in order toprotect the device itself or to protect the bone or soft tissue, forexample in a patient with an intramedullary tibial implant, in which theexternal moving magnetic field is placed extremely close to thepermanent magnet 162, and thus able to apply a significantly largetorque to it.

FIGS. 14-16 illustrate an alternative magnetic assembly 476 which can beadjusted upon assembly in order to set a specific amount of slip torquebetween the permanent magnet 162 and the magnet housing 464 and end cap466. A wave disc 302 (similar to a wave washer, but without a centerhole) is held between a flat washer 304 and an adjustable compressionstage 306. The flat washer 304 serves to protect the permanent magnet162 and also provide a consistent material surface for frictionpurposes. The wave disc 302 may be made from stainless steel, and theflat washer 304 may be made from a titanium alloy. Adjustablecompression stage 306 has a shaft 316 with a male thread 308 which isengaged within female threads 310 of a cylindrical extension 468. A hextool may be placed within access hole 314 of the cylindrical extension468 and into female hex 312 of the shaft 316 of the adjustablecompression stage 306. Turning in one direction increases compression onthe wave disc 302 and thus increases the normal force and frictionalslip torque. Turning in the opposite direction decreases these values.Upon assembly, adhesive may be placed on the threads 308, 310 topermanently bond the adjustable compression stage 306 to the cylindricalextension 468 and maintain the desired amount of frictional slip torque.

The intramedullary bone transport device 100 having a longitudinal slit150 as shown in FIGS. 1-4 is configured to be implanted within a reamedmedullary canal. For example a 10.7 mm diameter device may necessitatereaming to a diameter of 11.0 mm to 13.0 mm. At the beginning ofimplantation, a certain portion of the longitudinal slit 150 is locatedwhere there is no bone (FIG. 5). Because the longitudinal slit 150 isthus exposed to both the internal environment of the medullary canal andthe soft tissue (muscle, etc.) of the limb being treated, there is apotential for biological tissue growth on the moveable portions of themechanism, such as the lead screw 160. One way to protect the threads ofthe lead screw 160, is by adding a special coating to the surface of thelead screw 160. Coatings may be applied a variety of ways, for examplethrough deposition, and preferably are biocompatible, hard, thin andresistant to adherence of body tissues or fluids. Exemplary coatingsinclude MoST® (based on molybdenum disulfide) or ADLC (AmorphousDiamond-like Carbon).

Though the coating of the lead screw 160 may prevent biologicaladherence, it may also be desired to prevent any ingrowth orprotuberance of bone material into the longitudinal slit 150. One reasonthat this protuberance may interfere with the treatment of the patientis that it may push against some of the dynamic structures of the bonetransport device 100, limiting their functionality. Another reason isthat ingrowth of bone into the longitudinal slit 150 may make removal ofthe bone transport device 100 more difficult, more or less “locking” itin place. Several embodiments of bone transport device 100 havingdynamic covers 320 are presented in FIGS. 17 through 19, each dynamiccover 320 with the capability of protecting the longitudinal slit 150from the ingrowth of bone, while still allowing for the functionality ofthe transport sled 152 mechanism of the bone transport device 100. FIG.17 illustrates a bone transport device 318 having a dynamic cover 320including two opposing combs 322, 324, each of whose teeth extendtowards the center line 326 of the longitudinal slit 328. The dynamiccover 320 substantially covers the portion of the longitudinal slit 328not occupied by the transport sled 152. Comb material may be chosen fromsuperelastic Nitinol, MP35N, Elgiloy® which are biocompatible and have agood combination of strength and repetitive bending characteristics.Individual comb teeth 334 may be 0.105″ in length, 0.050″ in width and0.003″ in thickness. Transport sled 330 has a specially angled prow 332on each end, the prows causing the teeth 334 of the combs 322, 324 oneach side to be pushed against the side of the slit 328 with relativelylow force as the transport sled 330 passes by that particular area. Theprow 322 is symmetric along the centerline 326. After the transport sled330 passes by, the teeth 334 return to their original position coveringtheir half of the slit 328. The angulation of the prow 332, allows thetransport sled 330 to slide past the flexing teeth 334 with minimalinterference or frictional force. An exemplary included angle of the topof the prow 332 (in relation to the centerline 326) is 60°. A moredetailed view of the transport sled 330 is seen in FIGS. 25A and 25B.Grooves 335 on each side of transport sled 330 allow transport sled 330to ride along rails 337 at edges of slit 328 along the open housing 331of bone transport device 318.

FIG. 18 illustrates a bone transport device 336 having a dynamic cover320 having a static ribbon 338 which covers the slit 340. Transport sled342 is configured to slide over the static ribbon 338. The bonetransport device 336 having a static ribbon 338 is shown in more detailin FIGS. 20 and 21. Static ribbon 338 is secured to the open housing 348at first end 344 and second end 346, both ends adjacent to slit 340.Static ribbon 338 is made of 0.002″ thick Nitinol and has a width of0.140″. A detailed view of the transport sled 342 is shown in FIG. 26.The transport sled 342 has a total width (W1) of 0.288″. A channel 350is wirecut in each end of transport sled 342, the channel 350 allows thestatic ribbon 338 to pass from the outside to the inside of transportsled 342 (and vice versa). During operation, the static ribbon 338 staysin place, while the transport sled 342 slides over it. The channel 350width (W2) is 0.191″, and channel thickness is 0.012″ giving enoughspace for the 0.002″ thick static ribbon 338 to slide freely withrespect to the transport sled 342. A first radius 352 and a secondradius 354 further aid in smooth sliding of the transport sled 342 overthe static ribbon 338. The centerline of channel 350 through each radius352, 354 follows a 0.036″ radius. As with many components of the bonetransport device 336, the transport sled 342 may be made from Titaniumalloy, for example titanium-6Al-4V. Alternatively, the components may bemade of cobalt chromium or stainless steel. By controlling the tensionat which the static ribbon 338 is held, the dynamic frictional force asthe transport sled 342 slides over the static ribbon 338 can be varied,but is typically on the order of about one pound. An alternative to bonetransport device 336 is envisioned, wherein the static ribbon 338 isreplaced by a ribbon which is fixedly secured to the transport sled 342,and which slides in a similar manner to a conveyor belt.

FIG. 19 illustrates a bone transport device 356 with a dynamic cover 320having a freely rotatable spiral-cut tube 358 configured to cover theslit 360. Spiral-cut tube 358 has a single spiral gap or cut 362 in itswall, helically oriented along its length. The width of the spiral gap362 in the axial direction is about the same as the length of thetransport sled 370. As the transport sled 370 moves in an axialdirection 372, the spiral cut tube 358 is forced to turn in a rotationaldirection 374, as the leading end 359 transport sled 370 contacts theedge 361 of the spiral cut tube 358 along the spiral gap 362. In thismanner, the spiral-cut tube 358 always covers the portion of the slit360 that is not already covered by the transport sled 370. Spiral-cuttube 358 may be formed from a number of different materials, such asPEEK (polyether ether ketone) or titanium, stainless steel or cobaltchromium.

An alternative to the mechanical dynamic covers 320 of FIGS. 17-19, aself-healing hydrogel may be coated or sprayed over the longitudinalslit 150. Hydrogels of this type have been described in “Rapidself-healing hydrogels” by Phadke et. al., Proceedings of the NationalAcademy of Sciences, Volume 109, No. 12, pages 4383-4388, which isincorporated by reference herein. A self-healing hydrogel acts likemolecular Velcro®, and can cover the area of the longitudinal slit 150.As the transport sled 152 moves longitudinally, the hydrogel is slitopen in the direction of longitudinal movement of the transport sled152, while the transport sled 152 moves away from an already slitportion of the hydrogel. By controlling the pH and side chain moleculelengths in the manufacture of the hydrogel, a hydrogel can be made thatboth allows the slitting by the transport sled 152 and allows therebinding of the prior slit.

FIGS. 22-24 illustrate an external adjustment device 378 configured forapplying a moving magnetic field to allow for non-invasive adjustment ofthe bone transport device 100, 318, 336, 356 by turning a permanentmagnet 162 within the bone transport device 100, 318, 336, 356, asdescribed. FIG. 22 illustrates the internal components of the externaladjustment device 378, and for clear reference, shows the permanentmagnet 162 of the bone transport device 100, 318, 336, 356, without therest of the assembly. The internal working components of the externaladjustment device 378 may, in certain embodiments, be similar to thatdescribed in U.S. Patent Application Publication No. 2012/0004494, whichis incorporated by reference herein. A motor 380 with a gear box 382outputs to a motor gear 384. Motor gear 384 engages and turns central(idler) gear 386, which has the appropriate number of teeth to turnfirst and second magnet gears 388, 390 at identical rotational speeds.First and second magnets 392, 394 turn in unison with first and secondmagnet gears 388, 390, respectively. Each magnet 392, 394 is held withina respective magnet cup 396 (shown partially). An exemplary rotationalspeed is 60 RPM or less. This speed range may be desired in order tolimit the amount of current density induced in the body tissue andfluids, to meet international guidelines or standards. As seen in FIG.22, the south pole 398 of the first magnet 392 is oriented the same asthe north pole 404 of the second magnet 394, and likewise, the firstmagnet 392 has its north pole 400 oriented the same as the south pole402 of the second magnet 394. As these two magnets 392, 394 turnsynchronously together, they apply a complementary and additive movingmagnetic field to the radially-poled, permanent magnet 162, having anorth pole 406 and a south pole 408. Magnets having multiple north poles(for example, two) and multiple south poles (for example, two) are alsocontemplated in each of the devices. As the two magnets 392, 394 turn ina first rotational direction 410 (e.g., counter-clockwise), the magneticcoupling causes the permanent magnet 162 to turn in a second, oppositerotational direction 412 (e.g., clockwise). The rotational direction ofthe motor 380 and corresponding rotational direction of the magnets 392,394 is controlled by buttons 414, 416. One or more circuit boards 418contain control circuitry for both sensing rotation of the magnets 392,394 and controlling the rotation of the magnets 392, 394.

FIGS. 23 and 24 show the external adjustment device 378 for use with abone transport device 100, 318, 336, 356 placed in the femur (FIG. 23)or the tibia (FIG. 24). The external adjustment device 378 has a firsthandle 424 for carrying or for steadying the external adjustment device378, for example, steadying it against an upper leg 420, as in FIG. 23.An adjustable handle 426 is rotationally attached to the externaladjustment device 378 at pivot points 428, 430. Pivot points 428, 430have easily lockable/unlockable mechanisms, such as a spring loadedbrake, ratchet or tightening screw, so that a desired angulation of theadjustable handle 426 in relation to housing 436 can be adjusted andlocked in orientation. Adjustable handle 426 is shown in two differentpositions in FIGS. 23 and 24. In FIG. 23, adjustable handle 426 is setso that apex 432 of loop 434 rests against housing 436. In thisposition, patient 438 is able to hold onto one or both of grips 440, 442while the adjustment procedure (for example transporting bone between0.10 mm to 1.50 mm) is taking place. It is contemplated that theprocedure could also be a lengthening procedure for an intramedullarybone lengthening device or a lengthening procedure for a lengtheningplate which is attached external to the bone. Turning to FIG. 24, whenthe bone transport device 100, 318, 336, 356 is implanted in a tibia,the adjustable handle 426 may be changed to a position in which thepatient 438 can grip onto the apex 432 so that the magnet area 444 ofthe external adjustment device 378 is held over the portion the bonetransport device 100, 318, 336, 356 containing the permanent magnet 162.In both cases, patient is able to clearly view control panel 446including a display 448. In a different configuration from the twodirectional buttons 414, 416 in FIG. 22, control panel 446 includes astart button 450, a stop button 452 and a mode button 454. Controlcircuitry contained on circuit boards 418 may be used by the surgeon tostore important information related to the specific aspects of eachparticular patient. For example, in some patients an implant may beplaced antegrade into the tibia. In other patients the implant may beplaced either antegrade or retrograde into the femur. In each of thesethree cases, it may be desired to transport the bone either from distalto proximal or from proximal to distal. There are thus six (6) differentscenarios. By having the ability to store information of this sort thatis specific to each particular patient within the external adjustmentdevice 378, the external adjustment device 378 can be configured todirect the magnets 392, 394 to turn in the correct directionautomatically, while the patient need only place the external adjustmentdevice 378 at the desired position, and push the start button 450. Theinformation of the maximum allowable bone transport length per day andmaximum allowable bone transport length per session can also be inputand stored by the surgeon for safety purposes. These may also be addedvia an SD card or USB device, or by wireless input. An additionalfeature is a camera at the portion of the external adjustment device 378that is placed over the skin. For example, the camera may be locatedbetween first magnet 392 and second magnet 394. The skin directly overthe implanted permanent magnet 162 may be marked with indelible ink. Alive image from the camera is then displayed on the display 448 of thecontrol panel 446, allowing the user to place the first and secondmagnets 392, 394 directly over the area marked on the skin. Crosshairscan be overlayed on the display 448 over the live image, allowing theuser to align the mark on the skin between the crosshairs, and thusoptimally place the external adjustment device 378.

FIGS. 27 and 28 illustrate an alternative embodiment to the anti-jammingend stop described in FIGS. 2-4 and in FIG. 10. Transport sled 152 hasbeen removed so that the rest of the anti-jamming assembly 482 canclearly be seen. Internal nut 456 is similar to internal nut 156 ofFIGS. 2-4, 10 in that it can be made, simply as an internal thread ofthe transport tube 154, or alternatively, it can be a separatecomponent. For example, the outer surface of the internal nut 456 may bemade with an external thread 458 and the inner surface of the transporttube 154 may be made with a mating internal thread. These two surfacesmay be bonded to each other, with adhesives, epoxies, etc., so that theinternal thread of the internal nut 456 mates with the external threads161 of the lead screw 160. In FIG. 27, a single pawl ring 460, having asingle pawl 462 is secured to the lead screw 160 by welding, adhesive,epoxy or other methods. The single pawl 462 thus turns in unison withthe lead screw 160. The end of the internal nut 456 has a ledge 470 atits end. This ledge 470 is configured to abut the single pawl 462 whenthe lead screw 160 reaches the end of its desired travel in relation tothe internal nut 456. In FIG. 27, there are several turns remaining inthe travel of the lead screw 160. In FIG. 28, the lead screw has reachedthe end of its desired travel and the single pawl 462 now abuts theledge 470, thus not allowing any more rotation in this direction for thelead screw 160. The opposing forces between the single pawl 462 and theledge 470 assure that the internal threads of the internal nut 456 willnot jam with the external threads 161 of the lead screw 160. Anothersingle pawl 480 at the opposite end of the internal nut 456 may be usedto engage with another ledge (not shown) at the opposite end of the leadscrew 160, thus eliminating jamming at the opposite end of travel of theinternal nut 456 and lead screw 160.

FIGS. 29 and 30 show an alternative anti-jamming assembly 484 to theembodiment of FIGS. 27 and 28. In FIG. 29, the end piece 472 of the leadscrew 160 has multiple pawls 474, which engage multiple ledges or teeth478 when lead screw 160 reaches the end of its travel. The stressbetween the pawl and ledge is now distributed amongst multiple pawls 474and ledges or teeth 478, thus also allowing a smaller axial dimension ofthe pawls 474 and ledges 478.

Returning to FIGS. 5 and 6, a bone transport procedure is described.After patient is prepped for surgery, a drill entry point 131 is chosento ream a hole in the medullary canal of the tibia 136. Intramedullarybone transport device 100 is inserted into reamed medullary canal andsecured with bone screws 126, 128, 130, 132, 134. Prior to creating anosteotomy 147, bone segment 144 for transport is chosen and secured totransport sled 152 with screw assemblies 112 as described herein.Osteotomy 147 is then made, freeing bone segment 144 from proximalportion of tibia 138. Osteotomy 147 may be made with osteotomes or aGigli saw. As an alternative, the osteotomy 147 may be made prior tosecuring the bone segment 144 to the transport sled 152. Prior torecovering the patient, a test transport procedure may be performed inthe operating theater, for example using an external adjustment device378 covered with a sterile drape. This test transport procedure may bedone either to confirm that the intramedullary bone transport device 100has not been damaged by the insertion procedure or to set the osteotomy147 at a desired initial gap distance, for example zero (0) to five(5.0) mm. The patient is then recovered, and within the first week aftersurgery, non-invasive bone transport procedures are initiated by thephysician, patient or family or friend of patient, typically consistingof transporting about 1 mm per day. For example 1 mm, once per day, or0.5 mm, twice per day, 0.33 mm, three times per day, etc. using theexternal adjustment device 378 as in FIGS. 23 and 24. As the bonesegment 144 transports, new bone 153 begins to form where the missingportion 142 had previously been. Towards the end of the patient'stransport period of treatment, the bone segment 144 nears the proximalend 135 of the distal portion 140 of the tibia 136. (All proceduresdescribed may be done on a variety of different bones.) A final gap 151may be decided upon by the physician, and when this final gap 151 isreached (for example, 5 mm), the surgeon may desire to do a graftingprocedure to facilitate the continuity of bone between the bone segment144 and the distal portion 140 of the tibia 136. The new bone 153 istypically allowed approximately one month per 10 mm of transportedlength to consolidate, but this time period can vary greatly dependingupon the biological characteristic (e.g. diabetes) and habits (e.g.smoking) of the patient.

FIG. 31A illustrates an intramedullary bone transport device 550 havinga reverse block and tackle arrangement according to another embodiment.A first housing portion 578 and a second housing portion 548 enclose theinternal reverse block and tackle components, shown in FIGS. 31B and 32.First housing portion 578 contains two slits 551 through which firsttension line 552 and second tension line 554 exit. After implantation,bone segment 144 is secured to tension lines 552, 554 using bone screwshaving a clamp feature at their tips that enters the intramedullarycanal and grips each of the tension lines 552, 554. The lead screw 556is turned by permanent magnet 162 and gear stages 180, 182, 184 as inother embodiments. The nut 558 moves along lead screw 556 in firstdirection 553 as lead screw 556 is turned. The tension lines 552, 554wrap around nut pulleys 566, 565 respectively (shown without nut 558 inFIG. 32). The nut pulleys 566, 565 are held rotatably to the nut 558 bypins 555, 557. The exit pulleys 563, 564 are held rotatably to the wireseal block 562 and first housing portion 578 with axle pin 574, whichmay be welded to the first housing portion 578 at each end. The tensionlines 552, 554 wrap around exit pulleys 564, 563 respectively. At theend of tension lines 552, 554 are crimped lugs 576, which are securedaxially within cavities in the wire seal block 562. A seal 570 issandwiched between the wire seal block 562 and a seal support plate 568by screw 572. The four (4) inner diameters 571 passing through the seal570 are sized to be slightly smaller than the outer diameter of thetension lines 552, 554, so that any body fluids entering through slits551 cannot enter further into the section of first housing portion 578and second housing portion 548 containing lead screw 556, nut 558,permanent magnet 162 and gear stages 180, 182, 184. The seal 570 is madefrom an elastomer such as EPDM, so that tension lines 552, 554 may movethrough inner diameters 571 while still maintaining a sealed condition.In FIG. 32, the nut 558 and the wire seal block 562 are not shown sothat more detail of the pathway of the tension lines 552, 554 may beseen. A guide rod 560 is secured to the assembly of the wire seal block562, seal 570, and seal support plate 568. The nut 558 has an off centerguide hole sized for sliding over the guide rod 560. As the nut 558moves in first direction 553 over turning lead screw 556, nut pulleys566, 565 move along with nut 558, causing each tension line 552, 554 tobe pulled around exit pulleys 564, 563, thus allowing tension lines 552,554 to pull bone segment 144 in second direction 559. Because of thereverse block and tackle arrangement, the tension lines 552, 554 move ata axial rate that is twice as fast as the rate of axial movement rate ofthe nut 558. Thus, for a nut 558 that travels only 55 mm total travelover lead screw 556, the tension lines 552, 554 are each pulled for 110mm total travel, allowing for a compact device which still produces alarge amount of bone transport length capability.

FIGS. 33 through 36 illustrate an intramedullary bone transport device528 according to another embodiment having a ribbon-driven transportsled 530. Lead screw 160 is driven by permanent magnet 162, with gearstages 180,182,184 as in FIGS. 1-4, however, the connection between leadscrew 160 and transport sled 530 is no longer direct. Nut 532 havinginternal threading is coupled to lead screw 160 and moves longitudinallyas lead screw 160 turns. Ribbon 534 is secured to nut 532, for exampleby welding or crimping, at one end and to transport sled 530 at theother end. Pulley 536 is rotatably coupled to enclosed housing 546 viaaxle 538. Ribbon 534 extends around pulley 536 so that movement of nut532 in first direction 540 pulls ribbon 534 around pulley 536, causingtransport sled to move in second direction 542. The multiple types ofdynamic covers 320 described in prior embodiments, would also be usablein this embodiment. The ribbon in FIGS. 33-36 is a single materialribbon made from Nitinol or stainless steel, for example 0.006″ thickNitinol ribbon. As yet a further embodiment, ribbon 534 may beconstructed of a laminate of several ribbon layers bonded together, forexample four layers of 0.002″ thick Nitinol or three layers of 0.003″thick Nitinol. The layers are bonded together with a flexible adhesive,such as a urethane adhesive, which allows the layers to slide slightlyin longitudinal relation to each other, as they move around the pulley536. Each of the layers may be a single ribbon structure as described,or may also be a multifilar, woven ribbon. The laminate constructionallows for a nut 532 that not only can pull transport sled 530, but alsopush transport sled 530, due to the increased column stiffness duringcompression. When this push/pull embodiments is in push mode, radii 544(as seen in FIG. 35) in the inner walls of enclosed housing 546 serve asa path for the ribbon 534 when the ribbon 534 is in compression(pushing). Ribbon 534 can refer to any analogous tensile member, forexample one or more wires or cables configured to extend around pulley536.

Other alternatives exist for constructing any of the embodimentspresented herein. As one example, instead of solid rare earth magnetmaterial, the magnets presented may be made as composite rare earthmagnets, such as those described in U.S. Patent Application PublicationNos. 2011/0057756, 2012/0019341, and 2012/0019342, which areincorporated by reference herein.

A maintenance feature, such as a magnetic plate, may be incorporated onany of the embodiments of the implant devices presented herein, such asthose described in U.S. Patent Application Publication No. 2012/0035661.

While embodiments of the present invention have been shown anddescribed, various modifications may be made without departing from thescope of the present invention. The invention, therefore, should not belimited, except to the following claims, and their equivalents.

What is claimed is:
 1. An implantable dynamic apparatus comprising: anail having a first portion and a second portion, the first portion ofthe nail configured for securing to a first portion of bone, the secondportion of the nail configured for securing to a second portion of bone;the second portion of the nail configured to be longitudinally moveablewith respect to the first portion of the nail, wherein the secondportion of the nail includes an internally threaded feature; a magneticassembly configured to be non-invasively actuated by a moving magneticfield; a lead screw having an externally threaded portion, the leadscrew coupled to the magnetic assembly, wherein the externally threadedportion of the lead screw engages the internally threaded feature of thesecond portion of the nail; wherein actuation of the magnetic assemblyturns the lead screw, which in turn changes the longitudinaldisplacement between the first portion of the nail and the secondportion of the nail; a first abutment surface coupled to the lead screw;a second abutment surface coupled to the second portion of the nail; andwherein the turning of the lead screw in a first direction causes thefirst abutment to contact the second abutment, stopping the motion ofthe lead screw with respect to the second portion of the nail, andwherein subsequent turning of the nail in a second direction is notimpeded by any jamming between the internally threaded feature and theexternally threaded portion.